Healgen Scientific Llc recalls Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is em…

Recall date

August 22, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3303-2024

FDA classification

Class II

Brand / firm

Healgen Scientific Llc

Sold / distributed

U.S. Nationwide distribution in the states of CA, GA and TX.

Why it was recalled

The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.